Multicomponent Breathlessness and Physical Activity Intervention in People With Asthma Using a Digital Platform
BRAID
2 other identifiers
interventional
300
1 country
2
Brief Summary
Treating breathlessness could help people with asthma have fewer symptoms and be more physically active. People with asthma report that it is important to deal with breathlessness during physical activity programs, but past research hasn't focused on this need. The investigators have developed a multicomponent digitally supported intervention targeting breathlessness and physical inactivity. This study will test whether the multicomponent digital supported intervention will help people with asthma. The main question the study aims to answer is: Does the multicomponent digitally supported intervention improve quality of life? Participants will:
- Be allocated to the intervention or usual care. Allocation to either group will be random (like tossing a coin).
- Attend study visits to complete an assessment involving questionnaires and measurements
- Receive telephone calls to ask questions about health
- Be invited to take part in an interview to have a conversation about thoughts on participating in the study
- Be asked to provide consent to collect information from Services Australia regarding use of health care services and medications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
February 19, 2026
February 1, 2026
2.1 years
August 24, 2025
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Asthma Quality of Life Questionnaire (AQLQ)
Items are rated on a 7-point Likert scale, with higher scores indicating better quality of life. A mean score across all items equally weighted is reported. The minimal clinically important difference has been estimated to be 0.5 units.
6-months
Secondary Outcomes (10)
Asthma Control Questionnaire-5 (ACQ-5)
6-months & 12-months
Shortness of Breathlessness with Daily Activities (SOBDA)
6-months & 12-month
Multidimensional Dyspnea Profile (MDP)
6-months & 12-month
Dyspnoea-12 (D-12)
6-months & 12-months
Physical activity
6-months & 12-months
- +5 more secondary outcomes
Study Arms (2)
Digital self-management platform and enhanced usual care
EXPERIMENTALEnhanced usual care
OTHERInterventions
Attend an in-person session with an respiratory nurse, focused on breathlessness and physical activity self-management; and be provided access to a digital self-management platform
Enhanced usual asthma tertiary care
Eligibility Criteria
You may qualify if:
- Aged 18 years or older
- Able to provide informed consent
- Evidence of variable airflow limitation within the past 10-years to confirm asthma diagnosis
- Meets diagnostic criteria for moderate, or severe asthma
- Reports breathlessness impacting daily life physical activities (modified Medical Research Council \[mMRC\] dyspnoea score ≥1) within the past 1-week
- Owns a smart device with internet access, which they are willing and able to use for the study duration
You may not qualify if:
- High dependence on medical care
- Significant life-limiting comorbidity (\<12 months life expectancy)
- Cognitive impairment, poor English language skills or significant untreated hearing impairment that prevents completion of data collection forms or understanding of verbal instructions
- Current participation in any other clinical trial, or participation in another clinical trial within the 4-weeks preceding study entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Hong Kong Polytechnic Universitycollaborator
- University of Sao Paulocollaborator
- The Thoracic Society of Australia and New Zealandcollaborator
- Hunter New England Local Health Districtcollaborator
- University of Newcastle, Australialead
- University of South Australiacollaborator
- Asthma Australiacollaborator
Study Sites (2)
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2025
First Posted
February 19, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
De-identified data may be shared through mediated access, managed by the designated data custodian, subject to (1) Explicit participant consent for data sharing and re-use obtained during the consent process, (2) appropriate data sharing agreements with requesting parties, and (3) review of the proposed re-use to ensure alignment with the original consent.